ETD

Digital archive of theses discussed at the University of Pisa

 

Thesis etd-12182019-174032


Thesis type
Tesina di master di II livello
Author
NISI, MARTINA
URN
etd-12182019-174032
Thesis title
Eventi avversi nello studio di fase II con exemestane a basse dosi nel carcinoma mammario in trial multicentrico internazionale
Department
MEDICINA CLINICA E SPERIMENTALE
Course of study
SPERIMENTAZIONE CLINICA IN MEDICINA INTERNA, EMATOLOGIA ED ONCOLOGIA
Supervisors
relatore Prof. Danesi, Romano
Keywords
  • Exemestane a basse dosi
  • carcinoma mammario
Graduation session start date
13/12/2019
Availability
None
Summary
The aromatase inhibitor exemestane (EXE) has shown to lower cancer incidence in high-risk postmenopausal women. However, undesirable symptoms and side effects (i.e., bone density loss, musculoskeletal ache, climacteric syndrome) may compromise patient motivation and adherence to a long-term preventive treatment.
The primary objective in this trial is to assess if the reduction in estradiol with EXE 25 mg/three times a week and EXE 25 mg/week is comparable with the standard dose of 25 mg/day of EXE.
We are conducting a multi-center (Galliera Hospital, IEO, Moffit, MDACC, Columbia) , pre-surgical, double-blind, non-inferiority phase IIb study in which 180 postmenopausal women will be randomized to receive either EXE 25 mg/day or 25 mg/three times a week or 25 mg/week for 4 to 6 weeks prior to surgery. Surgery will occur on day 29, 36 or 43 after treatment initiation. Eligible subjects are postmenopausal women with histologically-confirmed ER-positive (ER >10%) primary breast cancer candidates for surgery. Participants with T0-2, N0-1, Mx or with larger tumors who refuse neo-adjuvant therapy before surgery are eligible. Subjects are stratified according to participating site and body mass index (<25 kg/m2 versus >25 kg/m2). The data studied in this thesis are still blinded. Therefore in this thesis were analysed the typology of adverse effects found during the study and the predictions on the primary endpoint, confirmed when arms will be opened.
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